Fast-tracked therapies have saved lives

HIV, COVID-19 process should extend to cancer, Louise Binder writes.

When I was diagnosed with HIV in 1994, there were no approved drugs to treat it.

People were dying. We were desperate for at least one of the clinical trials that were underway to show promise. Finally, in 1996, the first

Phase II/III trials of combination drugs gave us hope. We needed them right away and we got them, not having to wait for Phase III trials to be completed, peer reviewed and published. Many lives were saved, including my own, by accepting a trial design that expedited access to patients with no other options.

There was good news last month when Dr. Scott Halperin, director of the Canadian Centre for Vaccinology (CCFV) at Dalhousie University, announced Canada’s first COVID-19 vaccine clinical trial. It was a bit of a surprise because it was expected to take at least a year to 18 months to identify a viable vaccine candidate for human trials.

Approximately 100 people will take part in the first phase of this trial. Generally, trials have three phases.

Trials generally take approximately five to seven years from start to finish. Halperin explained that due to the seriousness of the situation, the researchers would not wait for final results from each phase before moving to the next phase. They would look at preliminary results and if they were good enough, they would continue to completion of that phase but also start the next phase. This will significantly reduce the time to completion of the trial.

This is a repeat of what occurred during the HIV epidemic. Trials were rolled together into what were called Phase II/III trials to speed up the process and get badly needed drugs to dying people. Consent forms for participants clearly explained the potential increased risk this created as we would not have the long-term and largescale numbers of people in the trials. Participants were more than willing to take that higher risk in a situation where the alternative was certain death.

Good for Halperin and the federal government for allowing him and his team to expedite this trial in these dire circumstances.

I predict that if these trials are successful, governments will ensure this vaccine gets into people’s hands expeditiously as well, either by fast-tracking the public drug pricing and reimbursement reviews that can take years or perhaps by passing over them altogether.

The question I continue to struggle with is why we can fast-track trial design and approvals, and get life-saving treatments into people’s hands at breakneck speed in cases like COVID-19, but not for cancer patients and other serious conditions.

Surely the fact that one out of two Canadians will get cancer during their lifetime and one out of four die each year from some form of cancer is a good enough argument to follow the best practice set by research protocols for COVID-19 trials.

Let us learn from the HIV and COVID examples and apply them to cancer and other urgent patient needs. Treatments that show promise should follow an expedited pathway without delay while we continue to collect data. Participants will sign a consent form that will fully inform them of the benefits and risks of the trial treatment as known to date. Where Phase II trials show significant benefit for those in the treatment arm of the trial, the trial should be stopped, and all participants should get the treatment. No Phase III trial will be required as a condition of considering the drug for public reimbursement.

Lives will surely be saved. Louise Binder is a lawyer. She cofounded the Canadian Treatment Action Council (CTAC) in 1996 which advocated for better access to HIV treatments. She is health policy consultant for the Save Your Skin Foundation.